The journal is operated by institute A, and the editor is an employee of institute A. A manuscript was submitted late in 2014 by authors from institute B, a similar type of organisation in the same country. The manuscript was reviewed by two referees who both recommended publication following minor revision. One of the reviewers noted that the abstract contained a vague statement related to the effectiveness of a treatment for a major type of export from the country but there was no further detail in the main text. In addition, the issue of worker safety was raised in the introduction but not discussed elsewhere. There was also a lack of context for the work and a lack of relevant conclusions. The authors were asked to add more detail on each of these points.
In May 2015, the authors submitted a revised version of their manuscript, which contained more relevant information and references to support their statements. The editor and associate editor considered that the authors had dealt with the issues raised by the referees and accepted the paper. The paper was published on 4 July 2015.
A senior manager at institute B rang the editor a few days after publication. The manger stated that the original manuscript had been approved for submission by institute B but the revised manuscript had not, and asked the editor to remove the paper from the journal’s website immediately. The editor said that this was not possible and further explained that if institute B wanted the paper retracted then they would need to provide a written justification.
Within an hour, the editor received three emails from the manager at institute B. The first one said that the paper “contains errors and speculation which were not able to be addressed at the time of finalising the text, as the paper was not re-submitted to the institute B editorial process following review by the journal” and that institute B believed “the paper is not in the interests of furthering an accurate and complete scientific record of the research in this field and therefore respectfully ask that it is retracted”.
The second email said that the manager at institute B had “since been in contact with the industry group who funded the project and they believe the inaccuracies are ‘significant’. As such, I’d like to emphasis the urgency in our request. I understand that in general journal referees remain anonymous unless they choose to identify themselves. In this instance I’ve been asked if we are able to learn the identity of the referees. Would you please comment on this so that I may respond appropriately?”
The third email said “Since I was in touch with you earlier today, the funding agency has had feedback from the relevant government department who have offered their support with responding to ensure the paper is corrected. I think this indicates the concern that these parties have in ensuring the information is accurate. The errors of fact and subsequent speculation to consequences related to worker safety and fumigation efficacy are problematic.”
The editor gave this matter urgent attention by reviewing the paper and checking the journal’s ethical guidelines (which are those of COPE). They concluded that a retraction was not warranted because the majority of this paper had not changed post revision so the potentially misleading revisions amounted to just a small portion of an otherwise reliable publication. The editor also concluded that, in accordance with COPE guidelines, the authors should submit an erratum detailing the specific passages of text that were incorrect and provide factually correct rewording. The editor sent these conclusions in an email to the manager at institute B the same day and waited for an erratum to be submitted promptly given the apparent seriousness of the situation. The editor did not reveal the names of the referees as the journal operates a closed review process. The editor also alerted the journal’s overseas publisher to this issue in order to fast track the erratum.
Ten days later, no erratum had been submitted to the journal but the editor was copied into an email from the funding agency to the manager at institute B. The agency thanked the manager for drafting an erratum but advised them that the funding agency and government department considered the risk associated with publishing an erratum to be too great so one should not be published. The funding agency also asked that both institutes A and B “manage their processes to ensure that any similar event does not occur in future”.
The manager at institute B forwarded that same email to the editor with a note saying that an erratum would not be submitted. The editor replied expressing surprise that an erratum had been drafted (but not submitted) and that it was not up to the funding agency/government department to decide whether or not an erratum should be published. The editor explained that the authors had an ethical obligation to correct the scientific record if errors existed. However, if there were no factual errors but simply statements that some people happened to disagree with, then no erratum was necessary. The Editor asked the manager at institute B to confirm which of these situations was the correct one and the manager replied stating that there were “no errors in the paper”.
Since then, the editor has been advised by colleagues that the funding agency has been alleging that publication of this paper could harm a key export industry for the country and cause substantial economic losses, and that institute A was at fault by allowing its journal to publish such sensitive work. These allegations are being strongly refuted by institute A. At no point have the authors of the paper communicated with the Editor.
The Editor has submitted this case to highlight concerns that: • key stakeholders in a published work (but not the actual authors) have attempted to suppress legitimate scientific results because of possible economic and political damage to an export industry; • this is a serious breach of scientific ethics; • unfounded allegations have been levelled at the journal’s owner for allowing the paper to be published.
Question(s) for the COPE Forum
What further steps or alternative actions does COPE recommend be taken?
This is essentially a conflict of interest issue, not with the authors, but with the employers/funders, emphasising the ubiquitous nature of conflicts of interest. The editor proposed that having clear guidelines and examples for similar situations from COPE would be helpful to resist pressure from funders or employers.
The Forum congratulated the editor for standing her ground, and agreed that the editor had done the right thing here in not bowing to pressure from the funders. As a way of avoiding a similar situation in the future, a suggestion was to ask authors to submit a statement on “the role of the funding source” as a way of outlining the role of the funder and clarifying issues such as: did the authors have control of the data at all times, and did the funder have a role in the analysis or submission of the paper? This would also help define the roles of the authors and funders. The authors are the researchers and should be in control of the data. There should not be any pressure from the funding source to try to manipulate the analysis or interpretation of the results or to influence the decision on where to submit the paper for publication. Both parties need to understand their roles.
Some journals ask each author to complete a separate conflict of interest form, and this may be something the editor might consider for the future.
A suggestion from the Forum was to write an editorial, highlighting the issue. This is an important issue and also raises the fact that government or other funders can be as conflicted as private companies, and this is especially true in small countries and for journals that are national journals.
Author Written and approved by COPE Council June 2008 Version 1 2008 How to cite this COPE Council. Guidelines for the Board of Directors of Learned Society Journals. Version 1. October 2008 https://doi.org/10.24318/cope.2019.1.5
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Our journal was contacted by a representative of a company following acceptance of a manuscript that was based on a clinical study sponsored by that company. Upon acceptance, the senior author had forwarded a copy of the manuscript to the company, who had identified some discrepancies between the data presented in the article and an initial report that had been presented to them while the study was still underway. They stated that these discrepancies had been brought to the authors' attention but that a satisfactory resolution had not yet been reached and that they had requested a full independent audit.
The authors, who were copied on this correspondence, were asked by the journal to clarify the discrepancies. In a letter to the company and the journal, the authors responded to each of the concerns that had been raised. They stated that the discrepancies resulted to some degree from the use of a different analytic technique in the submitted article, citing the CONSORT statement as evidence that this technique has become the favoured form of analysis since the initial report, which was presented almost 15 years ago. They also acknowledged that one of the numbers presented in the initial report was inaccurate and that they had redone their analysis to ensure accuracy in their results. A revised manuscript was included with this letter.
The company responded that they were not satisfied with the authors' responses and repeated their request for an independent audit. The authors responded that they did not have the resources for an independent audit but would conduct an extensive internal one. The associate editor who had accepted the manuscript and a representative of the editorial board were asked to assess the company's claims and the authors' responses and they felt that the authors had satisfactorily answered the questions that had been raised.
The company contacted the ethics committee of the authors' institution and reported their concerns. The institution's CEO reported that the ethics committee, as well as the institution's board, had investigated the situation and found that while errors had occurred, they did not constitute research misconduct and that they did not see this as an ethics issue. They said that the decision regarding publication should be left to the discretion of the journal's editors.
Our publisher's legal team was consulted, and they felt that if the journal editors were satisfied with the authors' responses and the relevant changes to the manuscript, then they did not see any reason not to publish the paper. They also advised that our society's board of directors should review the situation and recommended that the case be submitted to COPE, a recommendation endorsed by the society's board.
The company continues to maintain that an independent audit is needed. The authors contend that the company is seeking to delay or stop publication of the article, perhaps because of its implications for a line of products produced by the company.
The Forum asked whether the company had any contract with the authors requiring them to have company approval before publication. The editor told the Forum that the only contract that was found was a 15 year old letter about the authors promising to produce results.
As the institutions found no evidence of misconduct, and the editor is satisfied with the paper, most agreed that the paper should be published but that the editor should perhaps consult the journal’s legal team and the society's board. All agreed the editor has done all the right things and ultimately it is his decision whether or not to publish. An editor does have a duty to publish good research.
The Forum thought it might be helpful to consider whether the editor is reacting differently because a commercial company is involved. Also, the editor should be prepared for any negative publicity or even legal ramifications if he publishes the paper. How will the editor handle letters from the company criticising the paper? Will he publish them?
Another suggestion was for the editor to write a commentary or editorial outlining the issues involved in this case.
Following review of the Forum discussion, the society's board of directors agreed to proceed with publication of the article. Rather than drafting a full editorial to explain the controversy, a footnote was added to the manuscript to explain the unusual delay between acceptance of the manuscript and publication. The authors were notified of this, and agreed to the proposed language for the footnote. The company that had raised the concerns was also notified that publication would proceed and provided with the relevant deadlines should they wish to submit an official correspondence. The correspondence arrived within days and it and a response from the authors were both published in the issue that followed the one with the article itself. Because the letters are now linked to the article and its entry in most citation databases, the company's concerns and the authors' response are now entered into the public record. The society and editors are grateful to the Forum for its advice; being able to say that an independent body had reviewed the situation was beneficial.
Our scientific/medical Society added a Special Symposium to its Annual Meeting Program. The symposium organiser, who is an academic member of the Society, invited seven speakers, all from academic institutions, in addition to himself to speak at the symposium. Support for the symposium as a whole was solicited independently by the Development Committee of the Society and had no influence on the composition and subject matter of the symposium, except that the sponsors wanted to have an Enduring Material (ie, publication) resulting from the symposium. The support included honoraria for the seven speakers, which were higher than those for other speakers at the meeting, in part because these speakers were requested to produce articles.
We wish to publish the papers (we expect them to be review articles) in our journal. To minimise printing costs we prefer that they be included in a regular issue of the journal, rather than in a special supplement. The articles will be subjected to the regular peer review process that we use for review articles. Our plans are for the symposium organiser to write a prologue disclosing the nature and sources of commercial support for the symposium. The papers will be grouped, immediately following this prologue at the end of a journal issue, and will be marked “Special Symposium Presentation—Review”.
Is this sufficient disclosure to satisfy questions of conflict of interest? Alternatively, would it be necessary to state within each article that the author received an honorarium (or support) for the preparation of the article? Also, would it be necessary to print a disclosure statement of financial interest and/or other relationship with commercial entities (including some symposium sponsors) for the authors of each article within their manuscript, although this is not the general current practice in our journal?
The Forum noted that for industry sponsored supplements, conflicts of interest (CoIs) would not appear on PubMed if the CoIs only appeared in the prologue. Hence the advice was to publish full disclosure for all authors in each of the articles individually. It is necessary to consider each paper as a separate entity, as in this age of internet use, papers in a supplement can be viewed individually. Therefore, it is essential to state within each article that the author received an honorarium for the preparation of the article and also to print a disclosure statement for the authors of each article within their manuscript of the financial interest and/or other relationship with commercial entities. The symposium sponsors should also be listed on each article. Those indexing and abstracting the articles should also be made aware of this so that each article is cited correctly on PubMed. The Forum noted that the journal may wish to have a written policy on supplements and was told that the Council of Science Editors (CSE) provides information on policies for supplements in its white paper on publication ethics (www.councilscienceeditors.org), which the editor may find useful. Above all, the process should be seen to be open and transparent.
Following the advice from the Forum, the editor has instigated a process whereby there will be footnotes on presentations and special symposium to be published together in an upcoming issue of the journal, which will take the form of: “This paper is based on a presentation at a Special Symposium on (date), (title), for which the presenting author received an honorarium. (Name of Author 1) has consulting and/or financial relationships with (List of Companies whether or not related to study). (Name of Author 2) etc. (Name of Author 3) and (Name of Author 4) have nothing to declare.”
After further inquiry with the Development Committee that the raised money, it was ascertained that the money was raised for the Annual Meeting and not specifically for the symposium. Therefore, it will not be possible to identify specific sponsors for the symposium.
We received a paper describing the results of an analysis of pathogen gene sequences from patients who had been given an investigational drug as treatment for their infection. The study had been done in Europe. One reviewer said that the paper did not explain whether the patients had been treated in the context of a trial or not and that no information about study sponsorship, ethical approval or patient consent had been included.
The reviewer was concerned that an attempt was being made to publish data without the approval of the trial sponsors. The editors rejected the paper but recommended that the authors submit it to a sister journal at the same publishing company, but that they would need to address all of the points raised. The paper was then submitted separately to the sister journal but without any response to the reviewer’s points. The authors eventually explained that the patients in this study had been enrolled in an expanded access program for the investigational drug, which was underwritten by governmental sources. This was not regarded as a trial, and the authors explained that gene sequencing was carried out as part of routine clinical care, following national treatment guidelines.
The editors felt that there were insufficient grounds for them to follow-up further, and decided to withdraw the paper from consideration at the sister journal, recommending that the authors describe the context for the study more fully in their paper when they prepare it for publication elsewhere.
Should we have done more; is it reasonable that ethical approval and informed consent would not be needed for this study?
The Forum commented that this is probably an example of different rules for ethical approval in different countries. This would seem to be the issue here. The Forum agreed that no further action was required and that the matter should not be pursued.
The journal followed the COPE Forum’s advice and did not take further action.
An online post-publication literature evaluation service aiming to highlight the best articles in medicine has received evaluation of articles published in supplement issues of journals. Given that many supplements are funded by pharmaceutical companies, should we have a different policy on how to handle such evaluations? If so, what suggestions do you have?
The committee felt that it is not necessary to dismiss supplements out of hand as some can be very informative (published abstracts, non-commercial supplements). On the other hand, some members of the committee felt that the conflict of interest combined with the commercial interests of the pharmaceutical companies should deter publication of any evaluations of supplements. The majority view, however, was that a different policy for supplements is not necessary, as long the sponsorship and conflict of interest issues are transparent. It should be made clear if funding is received from pharmaceutical companies.
An editorial board member of a journal submitted an unsolicited review article on a drug. The editor said the journal would consider the article, but suspected that the article had been commissioned or even written by a drugs company. S/he stipulated that the author must provide a financial disclosure statement before the article could be accepted. The journal published the review article, which had been refereed by two independent reviewers. The author disclosed in his competing interests that he had been a paid consultant for the company that markets the drug. Several months after publication, an agent for the drug company ordered reprints of the article. The agent requested the wording: “This literature review was supported by [X]” be included on the cover sheet of each reprint. The agent was advised that this statement could not be added because the author had not disclosed it. The agent insisted, so the journal contacted the author. The author asked: “Does the final article have these words or something that states the article was in part supported by [X]?” A copy of the agent’s wording and the competing interest statement from the published article were sent to the author, who replied that he was fine with it as long as the publisher was. The author was then asked to explain the extent of the drug company’s involvement in writing the review article. The author replied that the competing interest statement in the article was accurate; the review had been written independently of any pharmaceutical company, and that the requested statement from the agent was inappropriate. The author was contacted again to point out the contradiction in his two replies. At the same time the agent was asked to question the drug company as to whether it had paid the author to write the review, and to confirm the extent to which the drug company had been involved in preparation of the manuscript. The agent did not reply; neither did the drug company. Eventually, the agent cancelled the reprint order. The author finally replied to confirm that he had been confused by the original request, thinking that clarification of whether he was a paid consultant to the drug company was required. He said that when it became apparent in a follow-up email that the drug company wanted the extra statement added, he realised it was inappropriate. The author assured the editors that the drug company would write a letter of explanation soon. The letter has yet to arrive.
- This case raises serious concerns. The connection was not made clear and this is a full conflict of interest. - The paper should be retracted. - The author should be asked explicitly if s/he had been paid by drug companies to write this review.
An experiment on a volunteer in hospital was written up. The volunteer was an asthmatic who was stable at the time and given a combination of intravenous magnesium sulphate and salbutamol to observe the pharmacological effects. The drugs were given under supervision in intensive care as they carry some risk of cardiovascular side effects. The paper reports: "After discussion with colleagues, a volunteer was given the drugs to see what happened." There is no description of an informed consent procedure or ethics committee approval. Nor is there any report of arrangements made to cover the costs of the research, whether staff, bed use, drugs, use of equipment or arrangements for dealing with side effects.
This was clearly experimentation, but it was unclear whether this was done as part of emergency care. - The editor should write to the authors to ask them whether they obtained informed consent and ethics committee approval. - The editor should also write to the head of the institution to request an investigation.
A large study—parts of which have been published in several major journals— purported to show that a drug may reduce side effect X without acting through an important intermediate process Y. This suggests that the drug may have important advantages over similar drugs in its class, and indeed it had been marketed as such. But a critic thinks that the drug may indeed act through the intermediate process Y but that this had been disguised by the way in which the drug had been taken. This was not described in the major papers, but has now been reviewed in a comparatively minor study. The editor had tentatively agreed with the critic to consider publishing a paper that discussed the mechanism, but it had been difficult to find out information on the trial protocol. - Could the authors have deliberately misled readers by not describing the drug route? - Does this amount to deception?
- It is impossible to know from the initial information whether the authors deliberately attempted to deceive by disguising the manner in which the drug was taken. - Why had it been difficult to find out information on the trial protocol? Had the pharmaceutical company exerted pressure for this information not to be released? - The editor should publish something to the effect that the apparent benefit may arise from the manner in which the drug is taken.
Somebody—possibly a representative of a drug company or a PR acting for the company—rang an editor on behalf of study authors to say that she would guarantee to buy 1000 reprints if the journal would continue to consider for publication a study that conflicted with a policy that the journal had just introduced. “And”, she said, “I will buy you a dinner at any restaurant you choose.” The paper was rejected, but should further action be taken?
_ Generally drug companies have policies against PR companies approaching journals and if the drug company was identifiable then the editor could contact the company concerned to complain. _ The lead author of the study should be informed about the actions of individuals representing the product being discussed in the paper. _ The drug company might also want to know what the PR is doing on its behalf. One of the members relayed how in a similar circumstance he had complained to the drug company which had withdrawn its contract with the offending PR company.
The editor admitted that he could not remember the name of the person involved and was unable to trace the article, but he promised to mention the incident in the journal. He fulfilled his promise.